The development of Cognitive Behavioural Therapy (CBT) for chronic loneliness in children and young people: Protocol for a single-case experimental design

Loneliness is a significant problem for young people and is associated with a range of physical and mental health difficulties. Meta-analyses have identified that interventions aimed at young people who report loneliness as their primary problem are lacking within the literature. In adults, the most effective interventions for loneliness are those which target the underlying maladaptive social cognitions. Therefore, we have developed a modular Cognitive Behavioural Therapy (CBT) intervention for children and young people. The aim of this study is to conduct a multiple baseline single-case experimental design (SCED) to assess the efficacy, feasibility and acceptability of this intervention. In total 6–8 11–18-year-olds and their families will be recruited. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. Participants will complete a baseline assessment, before being randomised to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). Participants will then complete an average of 12 sessions of CBT, with the aim being to reduce their feelings of loneliness. Participants will then complete a 12-day post-intervention phase. Participant loneliness will be repeatedly assessed throughout the three phases of the intervention using the Three-item Loneliness Scale, which will be the primary outcome. Secondary outcomes will be reliable and clinically meaningful change on the UCLA Loneliness Scale, Revised Child Anxiety and Depression Scale (RCADS) and Strengths and Difficulties Questionnaire (SDQ). Feasibility and participant satisfaction will also be assessed and reported. Trial registration: ClinicalTrails.gov trial registration number: NCT05149963 (Date registered: 07.12.2021). https://www.clinicaltrials.gov/ct2/show/NCT05149963?term=cbt&cond=loneliness&draw=2&rank=1.

Participants will be recruited from schools, social media and word of mouth. Participants will attend a baseline eligibility assessment where they will complete a demographic questionnaire and parent and child-report measures of loneliness and mental health which should take an hour (see assessment measures document). To meet inclusion criteria young people will have to have been experiencing loneliness for more than 3-months and score above the mean on the UCLA Loneliness Scale (Russell, 1996). Participants will be excluded if there are significant risk issues, are currently receiving psychological therapy or are unable to access the intervention. Participants will receive a £25 voucher for completing the baseline assessment. Participants will be randomised to baseline lengths of 12-33 days. During the baseline phase participants will be asked to complete the 3 item +1 question UCLA loneliness scale and a diary of their social contacts daily, which should take 5 minutes per day. Participants will complete the same measures for each session throughout the intervention phase. During the post-intervention phase participants will be asked to complete the measures daily for a further 12 days. Participants will then complete a post-intervention assessment, where they will recomplete the questionnaire measures, given a feedback form on the intervention and asked how COVID-19/any other significant events have impacted their loneliness during the study. They will receive a £25 voucher for completing the post-intervention assessment. The primary outcome will be scores on the 3-item UCL loneliness scale. The results will be examined using visual analysis, Tau-U (Parker et al., 2011) and Jacobson's (Jacobson & Truax, 1992 Does your research involve any of the below? Children (under the age of 16),

Yes
Participants with cognitive or physical impairment that may render them unable to give informed consent,

No
Participants who may be vulnerable for personal, emotional, psychological or other reasons,

Yes
Participants who may become vulnerable as a result of the conduct of the study (e.g. because it raises sensitive issues) or as a result of what is revealed in the study (e.g. criminal behaviour, or behaviour which is culturally or socially questionable),

No
Participants in unequal power relations (e.g. groups that you teach or work with, in which participants may feel coerced or unable to withdraw),

No
Participants who are likely to suffer negative consequences if identified (e.g. professional censure, exposure to stigma or abuse, damage to professional or social standing),

No
Details, Participants will be young people (ages 11-18) and will include those with mental health conditions. The assessments and intervention will be conducted by Thomas Cawthorne, who is a Trainee Clinical Psychologist. He has a fully enhanced DBS check and several years experience working with children and young people. The study is supervised by Professors Roz Shafran and Andy Macleod who are both highly experienced Consultant Clinical Psychologists. During the intervention work, Thomas will received weekly supervision from Professor Roz Shafran.
During the consent process, we will get permission from all participants to inform their GP that they are involved in the study, as is good clinical practice. All participants will complete a baseline eligibility assessment. As part of this we will conduct a risk assessment and participants will not meet inclusion criteria if there are significant risk issues, e.g. significant suicidal ideation, previous suicide attempts, violence towards parents/siblings or significant safeguarding concerns with primary caregiver. If such issues were identified during the baseline assessment participants would be signposted to their GP and other appropriate agencies, e.g. CAMHS, and we would inform their GP of the risk issues identified by letter.
If risk issues are identified during the study, they would be discussed in the weekly supervision with Professor Roz Shafran and if necessary their GP will be informed and participants would sign posted to appropriate support agencies.
At the end of the study participants will be given a debrief sheet, where it will state that they should contact their GP if they require further support.

Design and Data
Does your study include any of the following?
Will it be necessary for participants to take part in the study without their knowledge and/or informed consent at the time?, No